EP1251808A1 - Einhand-manipulierbarer ring zur magenverengung - Google Patents

Einhand-manipulierbarer ring zur magenverengung

Info

Publication number
EP1251808A1
EP1251808A1 EP01907649A EP01907649A EP1251808A1 EP 1251808 A1 EP1251808 A1 EP 1251808A1 EP 01907649 A EP01907649 A EP 01907649A EP 01907649 A EP01907649 A EP 01907649A EP 1251808 A1 EP1251808 A1 EP 1251808A1
Authority
EP
European Patent Office
Prior art keywords
ring
catheter
strip
ring according
adjustment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP01907649A
Other languages
English (en)
French (fr)
Other versions
EP1251808B1 (de
Inventor
Salomon Benchetrit
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Original Assignee
Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA filed Critical Compagnie Europeenne dEtude et de Recherche de Dispositifs pour lImplantation par Laparoscopie SA
Publication of EP1251808A1 publication Critical patent/EP1251808A1/de
Application granted granted Critical
Publication of EP1251808B1 publication Critical patent/EP1251808B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0066—Closing devices for gastric bands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/003—Implantable devices or invasive measures inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013—Implantable devices or invasive measures
    • A61F5/005—Gastric bands
    • A61F5/0053—Gastric bands remotely adjustable
    • A61F5/0056—Gastric bands remotely adjustable using injection ports

Definitions

  • the present invention relates to the technical field of surgical implants intended for treating obesity by implantation of a flexible gastric band intended to tighten the stomach of a patient, said gastric band being provided with an annular compression chamber with volume variable and adjustable via an adjustment catheter connected to an adjustment and control device implanted in the patient's body.
  • the present invention relates to a gastroplasty ring formed by a flexible band intended to be closed around the stomach towards its two end parts, using a closure system to reduce the diameter of the stoma opening.
  • said strip comprising an annular compression chamber with adjustable volume, connected by an adjustment catheter to a device for adjusting the internal pressure of said chamber, to adjust its diametral expansion.
  • Surgical techniques involving a defect in absorption are, for example, those involving a bypass technique or bypass of the small intestine or those implementing separation of the passage of food relative to the digestive juices.
  • the surgical bypass technique can give rise to severe complications, so that this technique is very rarely used.
  • the surgical technique of separation of the passage of the food bolus relative to the digestive juices does not does not involve any particular complications, but requires significant surgical intervention, notably involving a partial gastrectomy.
  • Such techniques typically involve the use of gastroplasty rings implanted around the stomach to reduce its size and the diameter of its passage (stoma).
  • Most of the known gastroplasty devices and for example the one described in patent US-A-5074868, use a flexible strip made of elastomeric material and intended to be implanted around the stomach then tightened and closed according to a loop of fixed diameter by a closure system.
  • the body of the flexible band comprises a cavity or compression chamber of variable volume connected by an adjustment catheter to a device for adjusting the internal pressure of the chamber in order to vary the internal diameter of the loop to modify or adjust the diameter stoma by injection or extraction of a volume of liquid out of the chamber.
  • Such an operation for adjusting the internal diameter of the ring is carried out using conventional control devices including a miniaturized housing implanted directly under the patient's skin and provided with a self-sealing membrane through which the doctor injects or withdraw liquid by syringe.
  • US-A-5074868 implements a suturing, using sutures, of the two strands of the flexible band of the ring.
  • Such a device is generally satisfactory, but suffers, like most known systems, from drawbacks essentially linked to the difficulty of any surgical intervention likely to occur after the placement of the gastroplasty implant.
  • the placement of such gastric implants can be accompanied by phenomena of intolerance , for example accompanied by vomiting, linked to too strong a reduction in the diameter of the stoma, or to an ineffective action of the implant linked to a too large diameter of the stoma, or quite simply to discomfort or local infection or inflammation or general.
  • the utility model DE-G-90 14048 presents a partially annular system specifically designed and adapted to the total closure of vessels blood, the teaching of which cannot be transposed to the compression of the stomach which must be perfectly mastered.
  • the object assigned to the invention therefore aims to propose a new gastroplasty ring making it possible to remedy the various drawbacks listed above and capable of facilitating the surgical intervention as well as possible re-surgical interventions after placement of the implant, not requiring the replacement of the implant, the latter being in any case, of particularly simple design and easy to produce.
  • Another object of the invention is to propose a new gastroplasty ring capable of ensuring in a simple and reliable manner a reversible closure of the loop constituting the ring.
  • Another object of the invention is to propose a new gastroplasty ring capable of proposing simple and reliable means of adaptation and refined adjustment of the diameter of the ring to each given surgical situation.
  • Another object of the invention is to propose a new gastroplasty ring capable of having several implantation diameters.
  • Another object of the invention is to propose a new gastroplasty ring making it possible to facilitate threading of the catheter.
  • Another object of the invention is to propose a new gastroplasty ring which is particularly easy to manufacture while being of excellent general mechanical strength.
  • a gastroplasty ring formed by a flexible band intended to be closed around the stomach towards its two end parts by a closure system to reduce the diameter of the opening of the stoma
  • said strip comprising an annular compression chamber with adjustable volume and of substantially constant cross-section connected by an adjustment catheter to a device for adjusting the internal pressure of said chamber, for adjusting its diametrical expansion
  • the closure system comprises locking and loosening means of the ring which are carried by the adjustment catheter, making it possible to ensure, from their diametric locking position, the diametrical relaxation of the ring by relative displacement of the two end parts
  • FIG. 1 illustrates in a schematic perspective view, an embodiment of a gastroplasty ring according to the invention in the closed position.
  • FIG. 2 illustrates in a schematic perspective view, an embodiment of a gastroplasty ring according to the invention in the open position before implantation.
  • FIG. 3 illustrates in a cross-sectional view, the section of a gastroplasty ring according to the invention.
  • Figures 1 and 2 illustrate a preferred embodiment of a gastroplasty ring 1 according to the invention, formed by a flexible strip 2 produced for example by thermoforming from an elastomeric material for surgical use, said strip 2 defining , preferably substantially over its entire length, an internal compression chamber 3, delimited by the walls 4 of the flexible strip 2 and by two end portions 5, 6.
  • the compression chamber 3 In its position of implantation in the stomach of a patient, as illustrated in FIG. 1, the compression chamber 3 therefore forms an annular compression chamber, the section and profile of which are adapted to avoid the formation of a pinch zone capable of generating folds with the walls of the stomach.
  • the compression chamber 3 defines a closed and internal volume in the gastroplasty ring, which is intended to form an adjustable volume so as to regulate the diametral expansion of the ring when in place to adapt it to each given surgical situation.
  • an adjustment catheter 7 formed by a tubular element of elastomeric material extending one of the free end parts, by example the end part 5, of the compression chamber 3 for connecting said chamber to a device 8 for adjusting the internal pressure of said chamber.
  • the adjustment device 8 can be formed by a miniaturized housing 9 implanted under the skin of the patient.
  • the miniaturized housing 9 comprises for example an upper self-sealing membrane 10 intended to be pierced by a syringe to inject or withdraw a certain quantity of fluid (distilled water for example) serving to ensure the variation in volume of the compression chamber 3, to adjust the volume of the chamber and thus obtain the internal diameter of the desired ring.
  • a certain quantity of fluid distilled water for example
  • the gastroplasty ring according to the invention also comprises a closure system intended to close and maintain in a loop position the gastroplasty ring around the stomach.
  • the closure system comprises means for blocking and loosening the ring which are carried by the adjusting catheter 7, ie forming an integral part of the latter and making it possible to ensure, from the diametrical locking position of the ring corresponding to the closed and looped position as illustrated in FIG. 1, its momentary diametral relaxation by relative displacement of the two end parts 5, 6 of the ring, while forming if desired, a closed loop around the stomach.
  • the locking and loosening means are reversible.
  • the locking and loosening means comprise pneumatic means for closing and opening the ring, involving a fluid, a gas or a liquid for example.
  • pneumatic means for closing and opening the ring, involving a fluid, a gas or a liquid for example.
  • the gastroplasty ring according to the invention, comprises a closure system whose reversible locking and loosening means comprise at least one deformable zone 12 formed or made on the adjustment catheter 7, and an opening 15 formed in the wall 4 of the end part 6 of the strip 2, the inflatable adjustment catheter 7 which is made of a biocompatible elastomeric material, is intended to be threaded in the opening 15 in the closed position of the ring and to further serve as a guide means.
  • the deformable zone 12 is capable of forming a protrusion 13 in the event of an increase in pressure in the adjustment catheter 7, said protrusion 13 bearing against the walls 4 of the end part 6 of the strip, inside chamber 3 to lock the ring in the closed position.
  • the protuberance 13 resumes its form of rest in case of return to normal pressure in the adjustment catheter 7 to allow the sliding and the free guidance of said catheter in the opening 15 and the loosening of the loop.
  • the reversible deformable zone 12 is formed by at least one zone 13 of less resistance and in its rest form, constitutes a relief with respect to the rest of the section of the adjusting catheter 7.
  • the cross section of the deformable zone 12 at rest is of an area greater than that of the cross section of the rest of the length of the adjusting catheter 7 so as to form a kind of slight blistering on the surface catheter.
  • the deformable zone 12 can be formed by a section of the adjustment catheter 7 having a hardness of the elastomeric material making up the catheter, which is locally lower than the general hardness of said catheter.
  • the adjustment catheter 7 being connected to the external pressure adjustment device 8 via a fluid (air or liquid), the zone 12 will tend to form a balloon 13 of a larger diameter to the internal dimensions of the strip, which ensures the diametrical locking of the ring.
  • the pressurization of the balloon 13 takes place before that of the strip.
  • the invention may include several zones 12 of lower resistance, spaced regularly or not along the adjustment catheter 7 to form a gastroplasty ring capable of having several fixed delivery diameters.
  • the flexible strip 2 is provided at an end portion, and for example at the end portion 6 opposite the end portion 5 which is extended by the adjusting catheter 7, with a hollow sleeve 20 extending the flexible band 2.
  • the hollow sleeve 20 also has the opening 15 which is formed in one of its faces, preferably an external face, so that the other end 5 of the flexible strip 2 can be inserted into said sleeve in position closure, the adjusting catheter 7 then passing through the opening 15 to form the loop of the ring.
  • Such a constructive arrangement ensures good reliability of the holding of the closure, while allowing the compression chamber 2 to extend over the entire tightening perimeter of the stomach.
  • the strip 2 and the hollow sleeve 20 are of oblong cross section to further facilitate the wedging of the deformable zone 12 during its pressurization.
  • the flexible strip 2, the compression chamber 3 and the hollow sleeve 20 form a single piece made from the same elastomeric plastic material, the adjustment catheter 7 then being heat sealed.
  • the deformable zone 12 with a thickness different from the thickness of the flexible strip 2 in order to obtain different fluid flow rates in each of these elements.
  • These different flow rates can also be obtained by different shapes, in order for example to deflate the flexible strip 2 before the deformable zone 12.
  • the end part 5 of the strip 2 to which the adjustment catheter 7 is connected is preferably conical in shape to facilitate its insertion into the hollow sleeve 20.
  • the deformable zone 12 is located in the vicinity of the narrowed part of this conical shape.
  • the adjustment catheter 7 has visual locating means 25 which are located at a distance from the deformable zone 12 and which are intended, in the protuberance locking position 13, to pass through the opening 15 of the hollow sleeve 20
  • These visual identification means 25 consist for example of a ring with a diameter greater than that of the catheter. They make it possible to verify that the catheter has been sufficiently threaded into the opening 15 and in addition to ensure that the protuberance 13 blocked in the hollow sleeve 20 is maintained in position.
  • the adjustment catheter 7 is substantially rigid and is of considerable length relative to the diameter of the ring to facilitate the threading operation and the passage of the catheter 7 in the opening 15. This also allows a good positioning of the strip in the desired position. To facilitate threading, it is possible to produce the adjusting catheter 7, with an end portion of increased hardness relative to its portion adjacent to the protrusion 13, the portion of increased hardness then being cut after threading.
  • the latter has on its wall 4 gripping means 30 which consist of a surplus of material placed on the surface of this wall.
  • the closure system further comprises a female means placed inside the hollow sleeve 20 in order to further improve the blocking of the protrusion 13.
  • the female means takes the form of an eyelet against which the protrusion 13, or the balloon, expands and locks in position, under the effect of pressure.
  • the ring according to the invention is placed around the stomach in the position illustrated in FIG. 2.
  • the adjustment device 8 being disconnected beforehand, the surgeon ensures the threading and the passage of the adjustment catheter 7 through the opening 15 to insert the end 5 into the hollow sleeve 20 (FIG. 1). If necessary, the surgeon then reduces the length of the adjustment catheter 7 by cutting off the portion of increased hardness identified for example by a visual marker.
  • the surgeon can then, by means of the adjustment and inflation device 8 connected to the single catheter 7, ensure the locking in position of the ring, having first taken care to position the zone of least resistance 12 corresponding to the diameter of the desired implant, inside the sleeve 20, a visual check is carried out by means of the ring 25.
  • the surgeon can then ensure the adjustment of the internal diameter of the ring by injecting or withdrawing the quantity of suitable liquid through the catheter 7. It will be noted that all of these operations are carried out by means of a single catheter 7.
  • the invention finds its industrial application in the production and use of gastroplasty rings.

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nursing (AREA)
  • Public Health (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • General Health & Medical Sciences (AREA)
  • Obesity (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Prostheses (AREA)
  • Adornments (AREA)
  • Lenses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
EP01907649A 2000-01-20 2001-01-19 Einhand-manipulierbarer ring zur magenverengung Expired - Lifetime EP1251808B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR0000693 2000-01-20
FR0000693A FR2804011B1 (fr) 2000-01-20 2000-01-20 Anneau de gastroplastie a commande unique
PCT/FR2001/000185 WO2001052777A1 (fr) 2000-01-20 2001-01-19 Anneau de gastroplastie a commande unique

Publications (2)

Publication Number Publication Date
EP1251808A1 true EP1251808A1 (de) 2002-10-30
EP1251808B1 EP1251808B1 (de) 2008-12-10

Family

ID=8846097

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01907649A Expired - Lifetime EP1251808B1 (de) 2000-01-20 2001-01-19 Einhand-manipulierbarer ring zur magenverengung

Country Status (17)

Country Link
US (1) US7488336B2 (de)
EP (1) EP1251808B1 (de)
JP (1) JP4278900B2 (de)
CN (1) CN1171563C (de)
AT (1) ATE416737T1 (de)
AU (1) AU781040B2 (de)
BR (1) BR0107697B1 (de)
CA (1) CA2397550A1 (de)
DE (1) DE60136908D1 (de)
ES (1) ES2322331T3 (de)
FR (1) FR2804011B1 (de)
IL (1) IL150747A0 (de)
MA (1) MA25573A1 (de)
MX (1) MXPA02007050A (de)
PT (1) PT1251808E (de)
TN (1) TNSN02064A1 (de)
WO (1) WO2001052777A1 (de)

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US7500944B2 (en) 2003-06-27 2009-03-10 Ethicon Endo-Surgery, Inc. Implantable band with attachment mechanism
US7951067B2 (en) 2003-06-27 2011-05-31 Ethicon Endo-Surgery, Inc. Implantable band having improved attachment mechanism

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AT412525B (de) * 2003-07-25 2005-04-25 Wolfgang Dr Lechner Steuerbares magenband
AU2004281641B2 (en) * 2003-09-15 2010-06-17 Apollo Endosurgery, Inc. Implantable device fastening system and methods of use
EP2246013A1 (de) * 2003-10-23 2010-11-03 Proxy Biomedical Limited Magenzusammenzugsvorrichtung
KR101291439B1 (ko) * 2004-01-23 2013-07-31 알러간, 인코포레이티드 해제가능하게 고정할 수 있는 일체형의 조절가능한 위밴드
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FR2866555B1 (fr) * 2004-02-19 2007-02-09 Cie Euro Etude Rech Paroscopie Anneau chirurgical atraumatique
ATE444045T1 (de) * 2004-03-08 2009-10-15 Allergan Medical S A Verschlusssystem für röhrenförmige organe
CA2569043C (en) 2004-03-18 2010-08-17 Allergan, Inc. Apparatus and method for volume adjustment of intragastric balloons
WO2006086627A2 (en) * 2005-02-11 2006-08-17 Micardia Corporation Dynamically adjustable gastric implants and methods of treating obesity using dynamically adjustable gastric implants
US8251888B2 (en) 2005-04-13 2012-08-28 Mitchell Steven Roslin Artificial gastric valve
US9345604B2 (en) * 2005-05-02 2016-05-24 Almuhannad Alfrhan Percutaneous intragastric balloon device and method
US20060282107A1 (en) * 2005-05-09 2006-12-14 Kiyoshi Hashiba Intragastric device for treating obesity
US20060264982A1 (en) * 2005-05-20 2006-11-23 Viola Frank J Gastric restrictor assembly and method of use
US7691053B2 (en) * 2005-05-20 2010-04-06 Tyco Healthcare Group Lp Gastric restrictor assembly and method of use
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US10376399B2 (en) 2013-09-29 2019-08-13 Institut Hospitalo-Universitaire De Chirurgie Mini-Invasive Guidee Par L'image Implantable device to treat obesity

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US7500944B2 (en) 2003-06-27 2009-03-10 Ethicon Endo-Surgery, Inc. Implantable band with attachment mechanism
US7951067B2 (en) 2003-06-27 2011-05-31 Ethicon Endo-Surgery, Inc. Implantable band having improved attachment mechanism

Also Published As

Publication number Publication date
CN1395480A (zh) 2003-02-05
AU781040B2 (en) 2005-05-05
FR2804011A1 (fr) 2001-07-27
BR0107697B1 (pt) 2009-05-05
CN1171563C (zh) 2004-10-20
MA25573A1 (fr) 2002-10-01
DE60136908D1 (de) 2009-01-22
ATE416737T1 (de) 2008-12-15
ES2322331T3 (es) 2009-06-19
CA2397550A1 (en) 2001-07-26
AU3556401A (en) 2001-07-31
WO2001052777A1 (fr) 2001-07-26
FR2804011B1 (fr) 2002-07-19
JP2003520104A (ja) 2003-07-02
TNSN02064A1 (fr) 2004-03-05
EP1251808B1 (de) 2008-12-10
MXPA02007050A (es) 2004-03-19
BR0107697A (pt) 2002-10-15
JP4278900B2 (ja) 2009-06-17
IL150747A0 (en) 2003-02-12
PT1251808E (pt) 2009-03-06
US7488336B2 (en) 2009-02-10
US20030158564A1 (en) 2003-08-21

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